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510(k) Data Aggregation
(49 days)
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
A temporarily implantable material (non-resorbable) for use as a spacemaking barrier in the treatment of periodontal bone defects.
The Cytoplast™ Regentex Titanium 250 Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film reinforced with a titanium framework. The membrane has a nominal thickness of 250 microns. Membranes are supplied sterile in sealed pouches in a variety of shapes and sizes.
The biocompatibility of polytetrafluoroethylene (PTFE) and titanium has been established through a long history of use in a variety of implant devices. No additional biocompatibility testing has been conducted with this device.
Here's an analysis of the provided text regarding the Cytoplast Regentex Titanium 250 Non-Absorbable Barrier Membrane, presented in the requested format. It's important to note that the provided 510(k) summary focuses heavily on substantial equivalence to predicate devices rather than detailed performance studies with specific acceptance criteria and outcome data. Therefore, many sections will indicate "Not Applicable" or that the information is "Not provided in the document."
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Biocompatibility | Established through a long history of use of polytetrafluoroethylene (PTFE) and titanium in a variety of implant devices. |
| Effectiveness: Ability to function as a space-making barrier in the treatment of periodontal defects. | Concluded to be "safe and effective for its intended use and performs at least as well as the legally marketed predicate devices" based on substantial equivalence. Specifically, it is "identical in composition, function, and intended use to legally marketed predicate devices such as Gore-Tex™ Regenerative Material." |
| Performance compared to predicate devices. | "Performs at least as well as the legally marketed predicate devices." |
2. Sample size used for the test set and the data provenance
Not provided in the document. The submission relies on substantial equivalence to predicate devices, rather than a new performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no new performance study with a test set requiring expert ground truth establishment is described. The device's safety and effectiveness are established through comparison to predicate devices, whose performance would have been established previously.
4. Adjudication method for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a barrier membrane, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a barrier membrane, not an algorithm.
7. The type of ground truth used
Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices based on their prior regulatory approvals and clinical use. No new ground truth for a novel device performance study is described.
8. The sample size for the training set
Not applicable. The submission does not describe a training set as it is not an AI/ML device or a device requiring a specific training regimen for its function.
9. How the ground truth for the training set was established
Not applicable.
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